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510(k) K914887

ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT by Mallinckrodt Medical — Product Code FRQ

K914887 is an FDA 510(k) premarket notification submitted by Mallinckrodt Medical for the device "ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT". The FDA issued a decision of Substantially Equivalent on May 8, 1992. The device falls under product code FRQ (Tube, Levine), a Class II device regulated under 21 CFR 876.5980. Mallinckrodt Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1992
Date Received
October 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Levine
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Mallinckrodt Medical

  • K082520 — SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES (October 2, 2008)
  • K051416 — SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA (June 16, 2005)
  • K972258 — HI-CARE CLOSED SUCTION SYSTEM (December 29, 1997)
  • K971267 — SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EX (September 25, 1997)
  • K963732 — PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF A (June 26, 1997)
  • K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA) (March 28, 1997)
  • K965132 — HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES (March 20, 1997)
  • K962045 — ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT (November 26, 1996)
  • K962173 — SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES (October 4, 1996)
  • K955680 — SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED (March 13, 1996)

Other clearances for product code FRQ

  • K914530 — ICAN GT DRAINAGE BAG (December 18, 1991)
  • K802007 — PEDIWET=GUAZE IMPREGNATED WITH PETROL (September 26, 1980)

FDA data resources